Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2025-12-28 @ 12:55 AM
Study NCT ID:
NCT00958035
Status:
COMPLETED
Last Update Posted:
2012-01-05
First Post:
2009-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Bimatoprost Solution in Increasing Eyelash Prominence in African Americans With Eyelash Hypotrichosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007039', 'term': 'Hypotrichosis'}], 'ancestors': [{'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012996', 'term': 'Solutions'}, {'id': 'D000069580', 'term': 'Bimatoprost'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003008', 'term': 'Cloprostenol'}, {'id': 'D011461', 'term': 'Prostaglandins F, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area Head', 'organization': 'Allergan, Inc.'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'LATISSE®', 'description': 'bimatoprost ophthalmic 0.03% solution', 'otherNumAtRisk': 46, 'otherNumAffected': 14, 'seriousNumAtRisk': 46, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'vehicle sterile solution', 'otherNumAtRisk': 43, 'otherNumAffected': 4, 'seriousNumAtRisk': 43, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Eyelids Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Skin Hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'seriousEvents': [{'term': 'Hepatic Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Musculoskeletal Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Treatment Responders in Overall Eyelash Prominence at Month 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'LATISSE®', 'description': 'bimatoprost ophthalmic 0.03% solution'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'vehicle sterile solution'}], 'classes': [{'categories': [{'measurements': [{'value': '69.6', 'groupId': 'OG000'}, {'value': '48.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 4', 'description': 'Percentage of treatment responders in overall eyelash prominence, defined as at least a 1-grade improvement from baseline at Month 4 in the Global Eyelash Assessment (GEA) Scale. The GEA is a 4-point scale in which eyelash prominence is assessed from 1 (minimal prominence) to 4 (very marked prominence).', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat: All randomized subjects'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LATISSE®', 'description': 'bimatoprost ophthalmic 0.03% solution'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'vehicle sterile solution'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'LATISSE®', 'description': 'bimatoprost ophthalmic 0.03% solution'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'vehicle sterile solution'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '< 45 years', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': '45 - 65 years', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': '> 65 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-30', 'studyFirstSubmitDate': '2009-08-11', 'resultsFirstSubmitDate': '2011-11-30', 'studyFirstSubmitQcDate': '2009-08-12', 'lastUpdatePostDateStruct': {'date': '2012-01-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-11-30', 'studyFirstPostDateStruct': {'date': '2009-08-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Treatment Responders in Overall Eyelash Prominence at Month 4', 'timeFrame': 'Month 4', 'description': 'Percentage of treatment responders in overall eyelash prominence, defined as at least a 1-grade improvement from baseline at Month 4 in the Global Eyelash Assessment (GEA) Scale. The GEA is a 4-point scale in which eyelash prominence is assessed from 1 (minimal prominence) to 4 (very marked prominence).'}]}, 'conditionsModule': {'conditions': ['Hypotrichosis']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily to the upper eyelid margins (where the eyelashes meet the skin) compared with vehicle in increasing overall eyelash prominence in self-identified African American/ethnic black subjects exhibiting hypotrichosis of the eyelashes (inadequate or not enough eyelashes).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* African American/ethnic black\n* Adults at least 18 years of age\n* Eyelash prominence assessment of minimal or moderate\n\nExclusion Criteria:\n\n* Subjects with uneven lashes or longer on one side than the other\n* Any eye disease or abnormality\n* Eye surgery\n* Severe hyperpigmentation around the eye\n* Eyelash implants\n* Eyelash extension application\n* Any use of eyelash growth products within 6 months\n* Any use of prescription eyelash growth products\n* Treatments that may affect hair growth\n* Requiring eye drop medications for glaucoma'}, 'identificationModule': {'nctId': 'NCT00958035', 'briefTitle': 'Study of Bimatoprost Solution in Increasing Eyelash Prominence in African Americans With Eyelash Hypotrichosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': '192024-039'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LATISSE®', 'description': 'bimatoprost ophthalmic 0.03% solution', 'interventionNames': ['Drug: bimatoprost ophthalmic 0.03% solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'vehicle sterile solution', 'interventionNames': ['Drug: vehicle sterile solution (placebo)']}], 'interventions': [{'name': 'bimatoprost ophthalmic 0.03% solution', 'type': 'DRUG', 'otherNames': ['LATISSE®'], 'description': 'Apply one drop of study medication along the upper eyelid margin once daily in the evening', 'armGroupLabels': ['LATISSE®']}, {'name': 'vehicle sterile solution (placebo)', 'type': 'DRUG', 'description': 'Apply one drop of study medication along the upper eyelid margin once daily in the evening', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}